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| Name | Class |
|---|---|
| European Vision Institute Clinical Research Network | NETWORK |
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To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozurdex | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients. | Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients. | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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300-400 patients who have received at least 2 Ozurdex injections for the treatment of DME, were followed for at least 6 months after the last injection and with a minimal BCVA of 20/200 at baseline (before Ozurdex treatment).
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| Name | Affiliation | Role |
|---|---|---|
| Anat Loewenstein, Professor | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Kuopio University Hospital | Kuopio | 70211 | Finland | |||
| Department of Ophthalmology, Centre Hospitalier Henri Duffaut, |
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| Avignon |
| 84902 |
| France |
| Department of Ophthalmology, Croix Rousse University Hospital | Lyon | 69004 | France |
| Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University | Marseille | 13015 | France |
| Coscas Eye Clinic | Paris | 75006 | France |
| Department of Ophthalmology Lariboisière Hospital | Paris | 75475 | France |
| Ophthalmology Department, Kaplan Medical Center | Rehovot | 76100 | Israel |
| Department of Ophthalmology Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs | Bari | 7012 | Italy |
| Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara | Chieti | 66100 | Italy |
| Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael | Milan | 20132 | Italy |
| Centre for Clinical Trials, Department of Ophthalmology University of Padova | Padova | 35128 | Italy |
| G.B.Bietti Eye Foundation - IRCCS | Rome | 00198 | Italy |
| Department of Ophthalmology University of Udine | Udine | 33100 | Italy |
| Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image | Coimbra | 3000-548 | Portugal |
| Instituto de Retina e Diabetes Ocular de Lisboa (IRL) | Lisbon | 1050-085 | Portugal |
| Ophthalmology Department, Dos de Maig Hospital | Barcelona | 08025 | Spain |
| Hospital Vall d'Hebrón Department of Ophthalmology | Barcelona | 08035 | Spain |
| Instituto de Microcirugia Ocular | Barcelona | 08035 | Spain |
| Vallés Oftalmologia Research | Barcelona | 08195 | Spain |
| Ophthalmology Department, Hospital de LaPaz | Madrid | 28046 | Spain |
| Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe | Valencia | 460 | Spain |
| Retinal Clinic, St Eriks Hospital | Stockholm | SE-11282 | Sweden |
| Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust | Frimley | GU16 7UJ | United Kingdom |
| NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust | London | EC1V 2PD | United Kingdom |
| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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